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FDA Turns Back To CME as Opioid Control Tool

 
• By Cole Werble

Continuing medical education has been under attack in Washington in recent years, criticized as representing a way around FDA’s control of medical promotion. Now, FDA is turning back to CME as the keystone to controlling a tough drug overuse/abuse situation.

FDA-approved CME? That may be one outcome of the massive effort undertaken by the Food & Drug Administration to establish a class-wide Risk Evaluation & Mitigation Strategy for long-acting opioids.

Rather than focus on more restrictive ideas like patient registries and mandatory prescriber certification, the agency is proposing a relatively...

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Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.